DuBois J, Bruce S, Stewart D, et al. - Safety as well as good tolerability of setipiprant 1,000 mg BID (twice-daily) was evident but it lacked efficacy compared with placebo for scalp hair growth in men with androgenetic alopecia (AGA).

• A double-blind, multicenter, 32-week, phase 2a trial including males aged 18 to 49 years with AGA.

• A total of 169 patients were randomized, including 74 placebo, 83 setipiprant, and 12 finasteride subjects; 117 (69.2%) and 113 (66.9%) patients completed week 24 and 32 visits, respectively.

• Coprimary efficacy endpoints [alterations from baseline to week 24 in target area hair count and blinded Subject Self-Assessment of target area photographs] were not met.

• At week 24, setipiprant did not result in hair growth improvements vs placebo.

• Mild or moderate treatment-related adverse events were experienced by 12.3%, 25.9%, and 25.0% of the placebo, setipiprant, and finasteride groups, respectively.